Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16543 |
| Brand Name: | Fisher & Paykel Nasal CPAP prongs |
| Model: | BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10 |
| Affected: | multiple |
| Software version: | |
| Recalling Organisation: | Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place East Tamaki AUCKLAND 2013 |
| Contact Information: | 0800 503 553 |
| Manufacturer: | Fisher & Paykel Healthcare S.A. de C.V. |
| Brand Name: | Fisher & Paykel Bubble CPAP Starter Kits |
| Model: | BC461-SK. BC471-SK, BC490-SK, BC491-SK and BC492-SK |
| Affected: | 131007 - 140325 |
| Software version: | |
| Recalling Organisation: | Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place East Tamaki AUCKLAND 2013 |
| Contact Information: | 0800 503 553 |
| Manufacturer: | Fisher & Paykel Healthcare S.A. de C.V. |
| Issue: | Manufacturer has received customer reports relating to certain lot numbers of certain models of the nasal CPAP prongs detaching from the FPH FlexiTrunk Nasal Tubing. FPH introducred a new version of Nasal CPAP prongs in 2013 and the lot numbers and models incorporate this new version. Since the release of this new version FPH has received reports of the affected prongs detaching from the nasal tubing during use especially in the presence of mucous and/ or moisture. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/4/2014 |
